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YH001 + Envafolimab for Sarcoma
Study Summary
This trialtests a new treatment for advanced or metastatic sarcoma, combining YH001, envafolimab, & doxorubicin. Results will help decide if it can help certain types of sarcoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't taken steroids or immunosuppressants in the last 14 days.I am willing and able to give my consent to participate in the study.I have not had a heart attack or other serious heart problems in the last 6 months.I am either not able to have children due to surgery or a medical condition, or I can have children but agree to use birth control.I have had radiation therapy to the area around my heart or middle chest.I am not pregnant or breastfeeding.My organs are working well.My heart pumps well, with an ejection fraction over 50%.I have previously received T-cell or NK-cell therapy.I have a GIST or desmoid tumor.My advanced sarcoma has not been treated with immune therapy or doxorubicin.My advanced sarcoma is not responding to standard treatments.I am 18 years old or older.I am sterile or I agree to use a condom with spermicide.I am willing and able to follow the study's schedule and procedures.
- Group 1: P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WK
- Group 2: P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Group 3: P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WK
- Group 4: P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Group 5: P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WK
- Group 6: P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WK
- Group 7: P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Group 8: P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this investigation currently have vacancies for participants?
"The investigation, which had its initial launch on November 14th 2022 is currently recruiting patients. Information posted to clinicaltrials.gov has been updated as recently as December 5th 2022."
What overall goals is this experiment attempting to achieve?
"The primary purpose of this medical trial, which will last around 8 months, is to assess the objective response rate (ORR) of YH001 when administered with envafolimab and doxorubicin. Secondary objectives include determining the trough concentrations of both YH001 and envafolimab as well as YH001's concentration in isolation from other drugs."
What is the aggregate participant count for this exploration?
"Indeed, according to the information on clinicaltrials.gov this research is actively recruiting participants after being posted on November 14th 2022 and updated most recently on December 5th 2022. 176 individuals need to be recruited from a single site for this study."
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